Perspectives on Injectable HIV Pre-Exposure Prophylaxis: A Qualitative Study of Health Care Providers in the United States.

The introduction of injectable HIV pre-exposure prophylaxis (PrEP) has the potential to significantly change the biomedical HIV prevention landscape. However, effective implementation will require health care providers to adopt, prescribe, and administer injectable PrEP within clinical settings. This study qualitatively examined challenges and benefit of injectable PrEP implementation from the perspective of health care providers. From April to August 2022, we conducted 19 in-depth interviews with current PrEP-prescribing health care providers in New York State, including 3 physician assistants, 5 physicians, and 11 nurse practitioners. Interviews were audio-recorded, transcribed verbatim, and thematically analyzed to report semantic-level themes regarding injectable PrEP implementation. More than half of participants (61%) were aware of injectable PrEP; only 21% had experience prescribing it. Qualitative findings highlighted five themes. Three themes represented implementation challenges, including speculative concerns about side effects, appointment compliance, and practical and logistical considerations. The remaining two themes described benefits of injectable PrEP relative to oral PrEP, which included greater convenience and enhanced privacy. Findings from this qualitative study make significant applied contributions to the sparse knowledge on health care provider perspectives of injectable PrEP post-US Food and Drug Administration approval and their concerns and considerations regarding implementation in real-world clinical settings.

Safety and Immune Responses Following Anti-PD-1 Monoclonal Antibody Infusions in Healthy Persons With Human Immunodeficiency Virus on Antiretroviral Therapy.

Background: T cells in people with human immunodeficiency virus (HIV) demonstrate an exhausted phenotype, and HIV-specific CD4+ T cells expressing programmed cell death 1 (PD-1) are enriched for latent HIV, making antibody to PD-1 a potential strategy to target the latent reservoir. Methods: This was a phase 1/2, randomized (4:1), double-blind, placebo-controlled study in adults with suppressed HIV on antiretroviral therapy with CD4+ counts ≥350 cells/µL who received 2 infusions of cemiplimab versus placebo. The primary outcome was safety, defined as any grade 3 or higher adverse event (AE) or any immune-related AE (irAE). Changes in HIV-1-specific polyfunctional CD4+ and CD8+ T-cell responses were evaluated. Results: Five men were enrolled (median CD4+ count, 911 cells/µL; median age, 51 years); 2 received 1 dose of cemiplimab, 2 received 2 doses, and 1 received placebo. One participant had a probable irAE (thyroiditis, grade 2); another had a possible irAE (hepatitis, grade 3), both after a single low-dose (0.3 mg/kg) infusion. The Safety Monitoring Committee recommended no further enrollment or infusions. All 4 cemiplimab recipients were followed for 48 weeks. No other cemiplimab-related serious AEs, irAEs, or grade 3 or higher AEs occurred. One 2-dose recipient of cemiplimab had a 6.2-fold increase in polyfunctional, Gag-specific CD8+ T-cell frequency with supportive increases in plasma HIV RNA and decreases in total HIV DNA. Conclusions: One of 4 participants exhibited increased HIV-1-specific T-cell responses and transiently increased HIV-1 expression following 2 cemiplimab infusions. The occurrence of irAEs after a single, low dose may limit translating the promising therapeutic results of cemiplimab for cancer to immunotherapeutic and latency reversal strategies for HIV. Clinical Trials Registration. NCT03787095.

Trusted Information Sources About the COVID-19 Vaccine Vary in Underserved Communities.

The COVID-19 pandemic was one of the deadliest global public health events. In the United States, over 1.1 million individuals have died, and now COVID-19 is the third leading cause of death (CDC, 2023). Vaccine uptake has stalled among different demographics. Vaccine hesitancy, a delay in accepting or refusing vaccines, poses a significant challenge regardless of the availability of safe and effective COVID-19 vaccines. This study aimed to identify disparate COVID-19 vaccine uptake among individuals in Western New York. The primary objective was to identify the factors contributing to lower rates of COVID-19 vaccination within this population.Data were collected from 585 adults recruited from 20 Niagara and Erie Counties sites using a self-administered survey on vaccine hesitancy, vaccination status, and COVID-19-related characteristics. The survey included the adult Vaccine Hesitancy Scale (aVHS) and acquired information on demographic characteristics and COVID-19 impact, knowledge, and information sources. Data were analyzed using descriptive statistics, a chi-squared test, a Wilcoxon rank-sum test, and a logistic regression model.Findings suggest that unvaccinated participants (n = 35) were concerned about vaccine side effects (48.6%). For vaccinated/unboosted participants (n = 52), they (40.0%) reported clinical concerns. After adjusting for gender and age, healthcare provider guidance and family guidance remained significant predictors of vaccination status, while clinical research studies were significant predictors of booster status. Findings from this study suggest public health interventions that target vaccine education and facilitate well-informed decisions about COVID-19 vaccines lead to less vaccine hesitancy.

Addressing food insecurity in HIV care: perspectives from healthcare and social service providers in New York state.

Ending the HIV epidemic in the United States will require addressing social determinants contributing to poor care engagement among people living with HIV (PLH), such as food insecurity. Food insecurity is associated with poor care engagement among PLH. Yet, few studies have examined the perspectives of healthcare and social services providers on addressing food insecurity in HIV care. Guided by the Social Ecological Model, we conducted semi-structured interviews with 18 providers in New York State to understand barriers and facilitators to addressing food insecurity in HIV care. Thematic analysis illustrated eight themes across various levels of the Social Ecological Model. At the patient-level, providers perceived patients' feelings of embarrassment, shame, and judgement, and low health literacy as barriers. At the provider-level, challenges included limited time. Facilitators included fostering strong, patient-provider relationships. Barriers at the clinic-level included limited funding, while clinic resources served as facilitators. At the community-level, challenges included intersecting stigmas arising from community norms towards PLH and people who receive food assistance and limited access to healthy food. Findings suggest the need to incorporate their insights into the development of interventions that address food insecurity in HIV care.

Prevalence of depression among people living with HIV in rural hospitals in South-Western Nigeria-Association with clinico-demographic factors.

Major depression is the most common neuropsychiatric disorder among people living with HIV (PLWH) and is predictive of high morbidity and mortality among them. This study estimated the prevalence and explored factors associated with depression among PLWH in two rural secondary health facilities providing anti-retroviral therapy (ART) services in Southwestern Nigeria between September and December 2020. The Patient Health Questionnaire-9 (PHQ-9) was used to screen and identify PLWH aged 18 years or older with depression. Descriptive statistics, bivariate and multivariate analyses were performed with SPSS version 23. A total of 172 respondents were screened. The prevalence of depression was 16.3% (95% CI 11.1%, 22.7%). Mild, moderate, and moderately severe depression was identified in 17 (9.9%), 8(4.7%) and 3(1.7%) of the participants, respectively. One (0.6%) respondent had suicidal ideation. Of PLWH with any depression, 20/28(71.4%) were within the 40-59 years of age range. None of the participants was on antidepressants. The factor most associated with depression was hypertension, with adjusted odd ratios of 9.8(95% CI 3.5-27.3, p < 0.0001). The study highlights the importance of screening for the severity of depression among PLWH in rural hospitals providing ART services in Africa. PLWH with comorbid hypertension were more likely to suffer from some form of depression.

The impact of food insecurity on receipt of care, retention in care, and viral suppression among people living with HIV/AIDS in the United States: a causal mediation analysis.

Introduction: Attaining The Joint United Nations Programme on HIV/AIDS 95-95-95 targets to end the HIV epidemic by 2030 will require a greater understanding of the underlying mechanisms influencing care engagement among people living with HIV/AIDS (PLWHA). One such mechanism is food insecurity, defined as limited or uncertain access to food. Food insecurity has been shown to significantly impact HIV outcomes. Yet, few studies have examined the mechanisms through which food insecurity may influence these outcomes. We aimed to examine the effects of nutritional, behavioral, and mental health mechanisms through which food insecurity may impact HIV care continuum outcomes: receipt of care, retention in care, and viral suppression. Methods: We conducted a cross-sectional study of 200 PLWHA in New York State, United States from May-August 2022. Participants were recruited using convenience sampling methods. Multivariable logistic regression models were conducted to examine the associations between food insecurity and care continuum outcomes (receipt of care, retention in care, viral suppression), adjusting for age, race, ethnicity, education, income, and marital status. Individual causal mediation analyses were conducted to assess whether behavioral, mental health, and nutritional mechanisms mediated the hypothesized associations. Results: The median age of participants was 30 years (IQR: 27-37 years). The majority self-identified as Black (54.0%), male (55.5%) and straight/heterosexual (63.0%). Increasing severity of food insecurity was associated with greater odds of non-retention in care (aOR: 1.35, 95% CI: 1.07, 1.70) and viral non-suppression (aOR: 1.29, 95% CI: 1.08, 1.54). For the impact of food insecurity on non-retention in care, there was an indirect relationship (natural indirect effect; NIE) mediated through Body Mass Index (BMI) (ORNIE: 1.08, 95% CI: 1.00, 1.18). For viral non-suppression, there was an indirect relationship mediated through BMI (ORNIE: 1.07, 95% CI: 1.00,1.16) and an indirect relationship mediated through depression (ORNIE: 1.27, 95% CI: 1.07, 1.47). Discussion: Food insecurity was associated with greater odds of non-retention in care and viral non-suppression among PLWHA. Nutritional and mental health pathways are important mediators of these relationships. Results highlight the need for interventions to target these pathways to address food insecurity as an underlying mechanism influencing engagement in HIV care.

Seroprevalence and Genotype Diversity of Hepatitis C Virus in the Caribbean-A Review.

Hepatitis C (HCV) continues to present a global public health challenge, with no vaccine available for prevention. Despite the availability of direct-acting antivirals (DAAs) to cure HCV, it remains prevalent in many regions including the Caribbean. As efforts are made to eliminate HCV from the region, existing barriers, such as the high cost of DAAs and lack of an established database of HCV cases within the Caribbean, must be addressed. This review seeks to assess epidemiologic trends (seroprevalence and genotypic diversity) of HCV in the Caribbean and identify gaps in surveillance of the disease. The literature for the period 1 January 2005 to October 2022 was reviewed to gather country-specific data on HCV across the Caribbean. References were identified through indexed journals accessed through established databases using the following keywords: Caribbean, genotype distribution, and general epidemiologic characteristics. The usage pattern of HCV drugs was determined from information obtained from pharmacists across the Caribbean including Jamaica. The prevalence of HCV in the Caribbean was 1.5%; the region should therefore be considered an area of moderate HCV prevalence. The prevalence of HCV among intravenous drug users (21.9-58.8%), persons living with HIV/AIDS (0.8 to 58.5%), prisoners (32.8-64%), and men who have sex with men (MSM) (0.8-6.9%) was generally higher than in the general population (0.8-2.3%). Genotype 1 (83%) was most prevalent followed by genotypes 2 (7.2%) and 3 (2.1%), respectively. Less than 50% of countries in the Caribbean have reliable or well-curated surveillance data on HCV. Drugs currently being used for treatment of HCV infections across the Caribbean include Epclusa (sofosbuvir/velpatasvir) and Harvoni (ledipasvir/sofosbuvir). Some of these drugs are only available in the private sector and are sourced externally whenever needed. While trends point to a potentially higher prevalence of HCV, it will require well-designed random surveys to obtain better estimates of the infection seroprevalence, supported by strong public health laboratory systems. DAAs that are pan-genotypic should translate into treatments that are affordable, accessible, and available to improve cure rates and reduce the HCV burden in the population.

Antiretroviral Therapy Intensification for Neurocognitive Impairment in Human Immunodeficiency Virus.

BACKGROUND: Neurocognitive impairment (NCI) in people with HIV (PWH) on antiretroviral therapy (ART) is common and may result from persistent HIV replication in the central nervous system. METHODS: A5324 was a randomized, double-blind, placebo-controlled, 96-week trial of ART intensification with dolutegravir (DTG) + MVC, DTG + Placebo, or Dual - Placebo in PWH with plasma HIV RNA <50 copies/mL on ART and NCI. The primary outcome was the change on the normalized total z score (ie, the mean of individual NC test z scores) at week 48. RESULTS: Of 357 screened, 191 enrolled: 71% male, 51% Black race, 22% Hispanic ethnicity; mean age 52 years; mean CD4+ T-cells 681 cells/µL. Most (65%) had symptomatic HIV-associated NC disorder. Study drug was discontinued due to an adverse event in 15 (8%) and did not differ between arms (P = .17). Total z score, depressive symptoms, and daily functioning improved over time in all arms with no significant differences between them at week 48 or later. Adjusting for age, sex, race, study site, efavirenz use, or baseline z score did not alter the results. Body mass index modestly increased over 96 weeks (mean increase 0.32 kg/m2, P = .006) and did not differ between arms (P > .10). CONCLUSIONS: This is the largest, randomized, placebo-controlled trial of ART intensification for NCI in PWH. The findings do not support empiric ART intensification as a treatment for NCI in PWH on suppressive ART. They also do not support that DTG adversely affects cognition, mood, or weight.

A framework for sustainable capacity-building for collaborative North-South translational health research and training in a resource-constrained setting.

INTRODUCTION: Success with highly active antiretroviral therapy (ART) for the human immunodeficiency virus (HIV) in developing countries has been attributed to collaborative North-South resource-sharing and capacity-building. Academic research and training programmes have contributed towards policy entrepreneurship in a manner that influenced capacity-building within health systems. However, the documented capacity-building frameworks rarely elucidate how such programmes can be designed and implemented efficiently and sustainably. METHOD: We implemented the University of Zimbabwe (UZ)-State University of New York at Buffalo (UB) collaborative HIV clinical pharmacology capacity-building programme in Zimbabwe in 1998. We intuitively operationalized the programme around a mnemonic acronym, "RSTUVW", which spells out a supportive framework consisting of "room (space), skills, tools (equipment)", underpinned by a set of core values, "understanding, voice (clout) and will". Subsequent to our two decades of successful collaborative experience, we tested the general validity and applicability of the framework within a prospective programme aimed at expanding the role of health professionals. RESULTS AND CONCLUSION: Based on this collaborative North-South research and training capacity-building programme which has been positively validated in Zimbabwe, we propose this novel mnemonic acronym-based framework as an extra tool to guide sustainable capacity-building through collaborative North-South implementation research. Its extended use could also include assessment and evaluation of health systems within resource-constrained settings.

Socio-Structural Factors and HIV Care Engagement among People Living with HIV during the COVID-19 Pandemic: A Qualitative Study in the United States.

Achieving HIV prevention goals will require successful engagement in each stage of the HIV continuum. The present study sought to understand the ways in which socio-structural factors influence HIV care engagement among people living with HIV (PLH) within the context of the ongoing COVID-19 pandemic. Twenty-five PLH were recruited from January to October 2021. Semi-structured interviews discussed various socio-contextual factors that influenced engagement in HIV-related care as a result of the pandemic. A thematic content analysis reported semantic level themes describing factors influencing HIV care following an integrated inductive-deductive approach. Qualitative analysis revealed three themes that either supported or hindered engagement in care within the context of the COVID-19 pandemic: (1) social determinants of health, (2) social support, and (3) modes of healthcare delivery. The results underscore the need to assess socio-structural factors of health as means to promote successful engagement in the HIV care continuum and shed new insights to guide future practice in the era of COVID-19.

Barriers to HIV Pre-Exposure Prophylaxis Uptake and Ways to Mitigate Them: Perspectives of Ghanaian Immigrants in the United States.

African immigrants in the United States experience disparities in HIV incidence. Pre-exposure prophylaxis (PrEP) effectively prevents HIV infection, yet uptake is low among racial and ethnic minorities. To better understand PrEP adoption among African immigrants, in March 2020, we conducted interviews with Ghanaian immigrants (N = 40) to explore the barriers and ways to overcome these barriers to PrEP adoption. Participants described several barriers (e.g., low HIV knowledge and risk perception, fear of social judgment, cultural values, and norms), which may impede PrEP adoption. We categorized these barriers according to the levels of the socioecological model (individual, interpersonal, community, and organizational/structural factors). Participants also identified strategies to overcome the barriers, such as providing comprehensive education on HIV and PrEP. Our research provides foundational knowledge that can inform future PrEP research with Ghanaian and other African immigrants and offers important insights into factors that may impact PrEP adoption in this population.

Impact of Tamoxifen on Vorinostat-Induced Human Immunodeficiency Virus Expression in Women on Antiretroviral Therapy: AIDS Clinical Trials Group A5366, The MOXIE Trial.

BACKGROUND: Biological sex and the estrogen receptor alpha (ESR1) modulate human immunodeficiency virus (HIV) activity. Few women have enrolled in clinical trials of latency reversal agents (LRAs); their effectiveness in women is unknown. We hypothesized that ESR1 antagonism would augment induction of HIV expression by the LRA vorinostat. METHODS: AIDS Clinical Trials Group A5366 enrolled 31 virologically suppressed, postmenopausal women on antiretroviral therapy. Participants were randomized 2:1 to receive tamoxifen (arm A, TAMOX/VOR) or observation (arm B, VOR) for 5 weeks followed by 2 doses of vorinostat. Primary end points were safety and the difference between arms in HIV RNA induction after vorinostat. Secondary analyses included histone 4 acetylation, HIV DNA, and plasma viremia by single copy assay (SCA). RESULTS: No significant adverse events were attributed to study treatments. Tamoxifen did not enhance vorinostat-induced HIV transcription (between-arm ratio, 0.8; 95% confidence interval [CI], .2-2.4). Vorinostat-induced HIV transcription was higher in participants with increases in H4Ac (fold increase, 2.78; 95% CI, 1.34-5.79) vs those 9 who did not (fold increase, 1.04; 95% CI, .25-4.29). HIV DNA and SCA plasma viremia did not substantially change. CONCLUSIONS: Tamoxifen did not augment vorinostat-induced HIV RNA expression in postmenopausal women. The modest latency reversal activity of vorinostat, postmenopausal status, and low level of HIV RNA expression near the limits of quantification limited assessment of the impact of tamoxifen. This study is the first HIV cure trial done exclusively in women and establishes both the feasibility and necessity of investigating novel HIV cure strategies in women living with HIV. CLINICAL TRIALS REGISTRATION: NCT03382834.

Utility of HIV support groups in advancing implementation research in resource-limited settings: experiences from an urban-setting HIV support group in Zimbabwe.

Support groups for people living with the Human Immunodeficiency Virus (HIV) have continued to evolve since their emergence over two decades ago. In addition to providing HIV education and fostering psychosocial support, recent efforts have shifted the focus to socio-economic activities and retention in care. The sense of urgency to adopt new treatment and prevention strategies in sub-Saharan Africa necessitates greater engagement of established HIV care programs, especially among researchers seeking to conduct implementation research, promote prevention strategies and optimize treatment as prevention. To maximize the utility of support groups in doing so, efforts to create an organized, collaborative framework should be considered. This paper aims to describe the process of refocusing an adult HIV peer-support group and illustrate how a structured program was strengthened to sustain implementation research in resource-limited settings, while promoting patient recruitment and retention. A multidisciplinary team of scientists supporting an HIV peer-support group spearheaded the implementation process that authored the successes, challenges and lessons documented over eight years. Psychosocial support, nutrition care and support, adherence education and income generating projects were the main interventions employed. The initiative resulted in seven peer-reviewed publications, submission of 23 scientific abstracts, scientific dissemination at 12 international conferences. Eleven research studies and 16 income generating projects were successfully conducted over eight years. More than 900 patients participated in peer-support group activities every month and 400 were engaged in income generating activities. This multidisciplinary structured program was valuable in the retention and recruitment of patients for implementation research and benefits extended to psychosocial support, microeconomic projects, and improved nutrition. The support group contributed to strengthening implementation research through providing a platform for identification of research priorities, patient recruitment and retention in studies and dissemination of research findings.

Exploring Awareness, Perceptions, and Willingness to Use HIV Pre-Exposure Prophylaxis: A Qualitative Study of Ghanaian Immigrants in the United States.

HIV/AIDS disproportionately burdens African immigrants in the United States. Oral pre-exposure prophylaxis (PrEP) is an effective prevention tool for people at high HIV risk, yet uptake is low among racial and ethnic minorities-particularly immigrants. This study explores the awareness, perception, and willingness to use PrEP among Ghanaian immigrants in the United States. WhatsApp, a social media platform, was used to recruit and conduct semi-structured oral interviews with 40 Ghanaian immigrants in March 2020. Interview questions explored awareness of PrEP (whether the participants knew or had knowledge of PrEP before the study), perceptions of PrEP and PrEP users, and willingness to use PrEP. Interviews were audiorecorded, and transcribed. We used NVivo-12 Plus to analyze transcripts for emergent themes. Our sample consisted of Ghanaian adult immigrants (N = 40, 57% male, 71% college educated, age = 32.8 ± 5.7 years, 68% had lived in the United States between 1 and 10 years) residing in 12 US cities. Four major themes emerged: (1) low awareness of PrEP; (2) positive perception of PrEP for HIV prevention; (3) divergent views on PrEP users; and (4) mixed views on willingness to use PrEP. This study presents formative qualitative work, which suggests that Ghanaian immigrants, despite having low awareness of PrEP, may be willing to use PrEP. A key study implication was that stigma reduction interventions might facilitate PrEP scale-up in this population.

Two decades (1998 to 2018) of collaborative human immunodeficiency virus clinical pharmacology capacity building in a resource constrained setting.

While important advances have been made in the prevention and treatment of Human Immunodeficiency Virus (HIV) infection, limited expertise and resource constraints to effectively manage rollout of HIV programs often contribute to poor treatment outcomes in Sub-Saharan Africa. In 1998, the University of Zimbabwe (UZ) and the University at Buffalo, State University of New York (UB), developed a collaborative clinical pharmacology capacity building program in Zimbabwe to train the next generation of HIV researchers and support rollout of the national HIV program. The collaboration was funded by research and training grants that were competitively acquired through United States of America government funding mechanisms, between 1998 and 2016. Thirty-eight research fellows were trained and a specialty clinical pharmacology laboratory was established during this period. Knowledge and skills transfer were achieved through faculty and student exchange visits. Scientific dissemination output included sixty-two scholarly publications that influenced three national policies and provided development of guidelines for strategic leadership for an HIV infection-patient adherence support group. The clinical pharmacology capacity building program trained fellows that were subsequently incorporated into the national technical working group at the Ministry of Health and Child Care, who are responsible for optimizing HIV treatment guidelines in Zimbabwe. Despite serious economic challenges, consistent collaboration between UZ and UB strengthened UZ faculty scholarly capacity, retention of HIV clinical research workforce was achieved, and the program made additional contributions toward optimization of antiretroviral therapy in Zimbabwe.

Cross-validation of a high-performance liquid chromatography nevirapine plasma assay in a resource-limited setting in Zimbabwe.

An international HIV pharmacology specialty laboratory (PSL) was established at the University of Zimbabwe to increase bioanalytical and investigator capacities. Quantitation of plasma nevirapine in samples from the AIDS Clinical Trials Group protocol 5279 was compared between the University of Nebraska Medical Center PSL and the University of Zimbabwe PSL. Both PSLs employed internally developed methods utilising reverse-phase high-performance liquid chromatography with ultraviolet detection. Eighty-seven percent of the cross-validation results exhibited ± 20% difference.

Impact of acute, oral ingestion of hypoxoside from African potato on hepatic and renal function tests in HIV infected patients on combination antiretroviral therapy.

OBJECTIVES: African potato (hypoxis hemerocallidea) is used against HIV to enhance immune-function, although no studies have evaluated its use in HIV infected individuals on combination antiretroviral therapy. The study aimed to evaluate the acute effects of orally administered hypoxoside, a constituent of African potato, on the hepatic and renal function in HIV infected individuals on tenofovir disoproxil fumarate/ lamivudine/ efavirenz regimen. METHODS: This was an open-label, two-period, fixed-sequence, pre-post test study, pilot design. Ethical approval was obtained from Medical Research Council of Zimbabwe (MRCZ A/2045) and Medicines Control Authority of Zimbabwe (MCAZ CT134/2016). Blood samples were collected before and after administration of African potato tablets. Tablets were administered orally once daily at 15mg/ kg hypoxoside for 10 days. Hepatic function tests (ALT, AST, ALP, GGT, albumin, total/ direct bilirubin); renal function tests (eGFR, blood urea nitrogen, creatinine), serum electrolytes (sodium, potassium, chloride) were assayed. STATA was used for statistical analysis. RESULTS: Twenty-six participants were enrolled (85% female). Median age (range) was 43 (28-52) years. Most had overweight Body Mass Index (46%) and were married (54%). No statistical difference was noted during hypoxoside for AST/ ALT/ ALP/ GGT/ albumin/ bilirubin. There were no changes in creatinine/ eGFR/ electrolytes. A mean significant increase in total protein (p=0.04) and decrease in blood urea nitrogen (p=0.04) were noted. CONCLUSION: Short-term exposure to hypoxoside from African potato appeared safe and was not associated with clinically significant changes in hepatic, renal function tests/electrolytes. There is further need to evaluate extent of systemic exposure during long-term use in a larger population.

Effectiveness of a psychological intervention delivered by general nurses for alcohol use disorders in people living with HIV in Zimbabwe: a cluster randomized controlled trial.

INTRODUCTION: There have been very few randomized clinical trials of interventions for alcohol use disorders (AUD) in people living with HIV (PLWH) in African countries. This is despite the fact that alcohol use is one of the modifiable risk factors for poor virological control in PLWH on antiretroviral therapy. METHODS: Sixteen clinic clusters in Zimbabwe were selected through stratified randomization and randomized 1: 1 to Intervention and Control arms. Inclusion criteria for individual participants were being adult, living with HIV and a probable alcohol use disorder as defined by a score of 6 (women) or 7 (men) on the Alcohol Use Disorders Identification Test (AUDIT). In the Intervention clusters, participants received 8 to 10 sessions of Motivational Interviewing blended with brief Cognitive Behavioural Therapy (MI-CBT). In the control clusters, participants received four Enhanced Usual Care (EUC) sessions based on the alcohol treatment module from the World Health Organisation mhGAP intervention guide. General Nurses from the clinics were trained to deliver both treatments. The primary outcome was a change in AUDIT score at six-month post-randomization. Viral load, functioning and quality of life were secondary outcomes. A random-effects analysis-of-covariance model was used to account for the cluster design. RESULTS: Two hundred and thirty-four participants (n = 108 intervention and n = 126 control) were enrolled across 16 clinics. Participants were recruited from November 2016 to November 2017 and followed through to May 2018. Their mean age was 43.3 years (SD = 9.1) and 78.6% (n = 184) were male. At six months, the mean AUDIT score fell by -6.15 (95% CI -6.32; -6.00) in the MI-CBT arm, compared to a fall of - 3.09 95 % CI - 3.21; -2.93) in the EUC arm (mean difference -3.09 (95% CI -4.53 to -1.23) (p = 0.05). Viral load reduced and quality of life and functioning improved in both arms but the difference between arms was non-significant. CONCLUSIONS: Interventions for hazardous drinking and AUD comprising brief, multiple alcohol treatment sessions delivered by nurses in public HIV facilities in low-income African countries can reduce problematic drinking among PLWH. Such interventions should be integrated into the primary care management of AUD and HIV and delivered by non-specialist providers. Research is needed on cost-effectiveness and implementation of such interventions, and on validation of cut-points for alcohol use scales in low resource settings, in partnership with those with lived experience of HIV and AUD.

Chemoradiation in Stage IIIB Cancer of the Uterine Cervix: A Review of the Zimbabwean Experience.

PURPOSE: Cervical cancer remains the leading cause of cancer morbidity and mortality among Zimbabwean women. Many patients present with stage IIIB disease. Although definitive concurrent chemoradiation (CCRT) is the standard of care, there is a paucity of data on the effect(s) of this intervention in resource-constrained and high HIV-prevalence settings. We investigated the differences in CCRT initiation practices, tolerability, and outcomes in this group. PATIENTS AND METHODS: We performed a retrospective analysis of data from hospital records for patients with stage IIIB disease who were treated over a 2-year period at Parirenyatwa Group of Hospitals. Outcome measures were documented treatment-related adverse events and early clinical tumor response. RESULTS: One hundred twenty-eight (37%) of 346 patients received CCRT, and 65 (51%) of 128 patients were infected with HIV. CCRT was prescribed mostly in patients with less extensive disease-not involving lower third vaginal walls, minimal pelvic sidewall involvement (P = .002), and higher CD4+ count (P = .02). Eighteen percent of recorded adverse events were high grade (≥ 3). One patient did not complete treatment, and 68.5% achieved complete clinical tumor response at 3 months post-CCRT. A higher proportion of complete clinical tumor response was noted in those patients who were young, HIV uninfected, had less extensive disease, CD4+ of 500 cells/mm3 or greater, received four or more cycles of chemotherapy, received brachytherapy, and had no treatment breaks. CONCLUSION: The study revealed that the use of CCRT to treat stage IIIB cervical cancer is low in Zimbabwe. Although several factors contribute, low CCRT uptake is mostly attributed to financial barriers. Well-selected patients tolerate the treatment and have good early clinical tumor response as expected. The role of CCRT for this patient group (and methods to make it available in resource-limited settings) must be further evaluated.